Research study investigating troriluzole as possible treatment for OCD
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
IRAS ID
294656
Contact name
Timothy McCormack
Contact email
Sponsor organisation
Biohaven Pharmaceuticals, Inc.
Eudract number
2020-004653-69
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 22 days
Research summary
OCD is pattern of unreasonable thoughts and fears(obsessions) that leads to repetitive behaviors(compulsions).OCD patients suffer from intrusive, obsessional thoughts that are typically ego-dystonic and commonly engage in time-consuming compulsive behaviors to attenuate their anxiety that can persist chronically over time. Existing therapies can significantly reduce symptoms in many patients. However, up to 60% of patients have an inadequate response to conventional pharmacotherapy. Troriluzole (BHV-4157) is glutamate modulating drug developed for the potential treatment of OCD as adjunctive therapy to standard of care treatments in subjects who have experienced an inadequate response to current pharmacotherapy. It is novel, rationally designed 3rd generation tripeptide prodrug of riluzole that potentially offers improved bioavailability, pharmacology, safety, and dosing. The primary purpose of this trial is to evaluate the efficacy of troriluzole as adjunctive therapy compared to placebo in subjects with OCD who have had an inadequate response to their current OCD treatment. This is a Phase III,multicenter, randomized, double-blind, placebo-controlled, 2- arm study designed to assess safety, tolerability, and efficacy of troriluzole as adjunctive therapy when added to SOC treatment in subjects with OCD who failed to respond adequately to their current pharmacotherapy.Subjects will be randomized to additionally receive placebo or troriluzole in ration 1:1. Visits may include physical examinations, blood tests, urine samples, body scans, and questionnaires.The study will be conducted in Europe and North America, and will include approximately 700 subjects, aged 18 to 65 (inclusive). Eligible participants must have a diagnosis of OCD, be 18 years of age or older, and meet other specific study criteria.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0137
Date of REC Opinion
8 Jul 2021
REC opinion
Further Information Favourable Opinion